Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127150061 | 12715006 | 1 | I | 2008 | 20160706 | 20160905 | 20160905 | PER | US-TEVA-675108USA | TEVA | 0.00 | M | Y | 72.64000 | KG | 20160905 | CN | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127150061 | 12715006 | 1 | PS | NUVIGIL | ARMODAFINIL | 1 | 150 TO 250 IN SMALL DOSES | UNKNOWN | 21875 | ||||||||||
| 127150061 | 12715006 | 2 | SS | NUVIGIL | ARMODAFINIL | 1 | UNKNOWN | 21875 | |||||||||||
| 127150061 | 12715006 | 3 | C | GABAPENTIN. | GABAPENTIN | 1 | 0 | ||||||||||||
| 127150061 | 12715006 | 4 | C | CLONAZEPAM. | CLONAZEPAM | 1 | 0 | ||||||||||||
| 127150061 | 12715006 | 5 | C | CAFFEINE. | CAFFEINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127150061 | 12715006 | 1 | Bipolar disorder |
| 127150061 | 12715006 | 2 | Mania |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127150061 | 12715006 | Inappropriate schedule of drug administration | |
| 127150061 | 12715006 | Product use issue | |
| 127150061 | 12715006 | Therapeutic response unexpected |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127150061 | 12715006 | 1 | 2008 | 0 |